Managing Study Shipment Exceptions

Carrier tracking can show where a study shipment is, but it cannot determine whether the shipment remains suitable for study use. Delays, damage, temperature excursions, lost shipments and incorrect deliveries each require a controlled exception process that protects investigational product, study continuity, subject safety and the integrity of accountability records.

Immediate Notification Is the First Control

Sites, carriers, couriers, depots and the study distribution team should know which events must be reported, to whom they must be reported, and within what timeframe.

The notification should capture the shipment identifier, study and site, affected device or material, quantity, condition, delivery status, and available photographs, temperature data or carrier records.

Quarantine Affected Product Until a Decision Is Issued

Affected product should be placed in quarantine and withheld from use until an authorized disposition is issued. The site should not assume that intact packaging means the contents are acceptable, nor should it discard damaged or misdelivered product without instruction.

Responsibility for assessing usability should be assigned in advance, involving the sponsor, manufacturer, quality function, clinical team and distribution provider according to the nature of the exception.

Evaluate the Evidence for Each Exception

For delayed or temperature-controlled shipments, the review should consider validated transit duration, actual temperature data, packaging performance, device stability, and any limits defined by the study.

Damage assessments may require inspection of both the shipper and the device packaging. Lost shipments require carrier investigation, evaluation of possible diversion or confidentiality risk, replacement planning, and reconciliation of inventory that has not been physically recovered.

Incorrect Deliveries Create Additional Risks

Product sent to the wrong site, investigator, patient or address may create accountability, privacy, authorization and chain-of-custody concerns.

Recovery or redirection should occur only through an approved process, with confirmation that the recipient has not opened, used, altered or improperly stored the shipment.

Replacement shipments should be linked to the original exception so that duplicate supply does not create unexplained inventory.

Document the Final Outcome

Every exception should have a documented outcome, such as release, return, replacement, rework, destruction or another approved disposition.

The record should also capture root cause where appropriate, corrective action, sponsor notification, protocol or regulatory reporting implications, and updates to shipment and accountability records.

Maintain Control Through Final Disposition

MDD Studies can help establish and operate study-specific exception controls, coordinate carriers and sites, maintain quarantine and investigation records, support replacement and reverse logistics, and ensure that final disposition is reflected across the study record map.

This gives sponsors a traceable process for resolving shipment failures without losing control of investigational product or study inventory.